BacterioPHAGE for Gastrointestinal Health 2 Study

NCT04511221 | Completed

• 1 other identifier: 19-9145H
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The BacterioPHAGE for Gastrointestinal Health-2 study is designed to determine if a commercial bacteriophage product can increase the survival and efficacy of probiotic bacteria that will be concurrently administered. Bacteriophages may act as prebiotics, which are traditionally defined as indigestible dietary components that selectively enhance specific bacterial species in the intestines to confer a health benefit. In this study, the "prebiotic" is a unique combination of bacteriophages, or viruses that infect bacteria. These phages are generally regarded as safe for human consumption and are presumed to function by infecting pro-inflammatory E. coli strains in the gut. The removal of these strains alters the gut environment to allow growth of more favorable bacteria, and the lysis products of these E. coli may be assimilated by beneficial species to enhance their populations.The phage product, PreforPro, has shown to be effective in culture-based and animal studies, but its efficacy in increasing specific probiotic species has not been demonstrated in humans. The investigators have previously shown that PreforPro is both safe and tolerable in a human population and does not broadly disrupt the gut microbiota as would be seen with antibiotic treatment.

Conditions

Mild Gastrointestinal Symptoms in Healthy Adults

Keywords

gastrointestinal; probiotic; bacteriophage; Bifidobacterium animalis subspecies lactis

Outcome Measures

Primary Outcomes (3)

• Gastrointestinal Symptoms

  A functional gastrointestinal questionnaire was used to assess pain and symptoms related to GI function, GI inflammation, Colon and small intestine pain

  Four weeks

• Bowel Function

  A record of all stools (using Bristol Stool Scale) was collected throughout the study

  Four weeks

• Microbiota Analysis

  16s sequencing and phage plating was conducted to assess phage activity and microbiota associated changes.

  Four weeks

Secondary Outcomes (4)

• Blood pressure

  Four weeks

• Endothelial Function

  Four Weeks

• Plasma Lipids

  Four weeks

• Comprehensive Metabolic Panel

  Four weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

15 mg capsule containing rice maltodextrin and medium chain coconut triglycerides

Other: Placebo

Bifidobacterium animals subsp. lactis BL04

ACTIVE COMPARATOR

15 mg capsule containing 1x 10\^9 CFU Bifidobacterium animals subsp. lactis BL04 with rice maltodextrin and medium chain coconut triglycerides as a filler material

Dietary Supplement: Bifidobacterium animals subsp. lactis BL04

Bifidobacterium animals subsp. lactis BL04+PreforPro

EXPERIMENTAL

15 mg capsule containing 1x 10\^9 CFU Bifidobacterium animals subsp. lactis BL04 and 1x10\^6 PFU of PreforPro (Commercial phage preparation) with rice maltodextrin and medium chain coconut triglycerides as a filler material

Dietary Supplement: Bifidobacterium animals subsp. lactis BL04+PreforPro

Interventions

Bifidobacterium animals subsp. lactis BL04+PreforPro DIETARY_SUPPLEMENT

One 15mg capsule taken orally each day

Bifidobacterium animals subsp. lactis BL04+PreforPro

Bifidobacterium animals subsp. lactis BL04 DIETARY_SUPPLEMENT

One 15mg capsule taken orally each day

Bifidobacterium animals subsp. lactis BL04

Placebo OTHER

One 15mg capsule taken orally each day

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy
• years old
• BMI 20 to 34.9

You may not qualify if:

• individuals less than 18 years of age or greater than 65 years of age
• outside of the BMI range of 20-34.9
• antibiotic or probiotic/prebiotic supplements within two months of the start of treatment
• use of statins, metformin, NSAIDs, MAO inhibitors, and botanical supplements that target the GI tract or gut microbiota
• current diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, and metabolic disorders
• pregnant and breastfeeding women
• unable to adhere to the study requirements

Sponsors & Collaborators

• Colorado State University: lead

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523-1571, United States

Location

Study Officials

• Tiffany L Weir, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment capsules are provided by Deerland Enzymes in coded packaging. Participants, investigators, and data assessors will not be provided the key to the codes. Once all data is entered and analyzed, the keys will be provided by Deerland.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Food Science and Human Nutrition

Model Details: Randomized, double-blinded, placebo controlled, parallel arm

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 13, 2020
• Study Start: October 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: March 31, 2020
• Last Updated: August 13, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)